Lifestyle Changes for Breast Cancer Risk Reduction

Overseen By Karen M. Basen-Engquist

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Invasive cancer, Renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how diet and exercise can lower the risk of breast cancer by reducing body fat and inflammation in women of normal weight. Participants will either begin a lifestyle program (Lifestyle Intervention) immediately or after a short wait. The program includes high-resistance exercises, aerobic training, and dietary guidance over 16 weeks. Postmenopausal women of normal weight who can exercise safely and have a higher risk of breast cancer due to body fat may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to valuable research that could lead to new preventive strategies for breast cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this lifestyle intervention is safe for reducing breast cancer risk?

Research shows that lifestyle changes focusing on diet and exercise are generally safe for participants. Studies have found that these programs can lead to moderate weight loss and better physical health without major side effects. For instance, one study found that women lost 3–4% of their weight over 24 months, indicating the program was well-tolerated.

Another study examined a comprehensive lifestyle program and found no major safety concerns. Participants in these studies engaged in activities similar to those in this trial, such as aerobic exercise and dietary changes, all performed safely.

Overall, lifestyle changes are considered safe and helpful for improving health. Participants usually do not experience serious side effects, making these programs a promising option for those looking to lower health risks through lifestyle changes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the lifestyle intervention for breast cancer risk reduction because it offers a holistic approach without relying on medications or invasive procedures. Unlike standard treatments that often focus on surgery, chemotherapy, or hormone therapy, this intervention uses high-resistance circuit training, aerobic exercise, and personalized dietary changes as preventive measures. This approach empowers individuals to actively participate in their health management and could potentially reduce risk factors associated with breast cancer through natural and sustainable lifestyle changes.

What evidence suggests that this lifestyle intervention is effective for reducing breast cancer risk?

Research has shown that lifestyle changes can help lower the risk of breast cancer. In this trial, participants in Group I will undergo a lifestyle intervention that includes high-resistance circuit training, aerobic training, and dietary counseling. One study found that individuals who followed a lifestyle program consumed less fat and more fruits and vegetables. Another study discovered that these programs can lead to a moderate weight loss of 3–4%. Physical activity is also linked to a lower risk of breast cancer. These changes might help reduce body fat and inflammation, which are factors in breast cancer risk. Participants in Group II will join a wait-list and complete the lifestyle intervention after 4 months. ^{6 7 8 9 10}

Who Is on the Research Team?

Karen M. Basen-Engquist

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for postmenopausal women who are of normal weight with a BMI between 18.5 and <25, have excess body fat, no history of invasive cancer except non-melanoma skin cancer, no major surgery within the last 3 months, can exercise safely, and work at MD Anderson Cancer Center but not directly under the study's principal investigator.

Inclusion Criteria

No contraindications to exercise (either no positive responses on the Physical Activity Readiness Questionnaire, or clearance from a health care provider certifying that the participant is healthy enough to exercise)

Has internet access on a computer or mobile device

I have not had major surgery in the last 3 months.

Exclusion Criteria

You are currently doing strength exercises that work all major muscle groups two or more times per week.

MD Anderson employees that report to the principal investigator of this study

Participants that cannot engage in the exercise program for more than three weeks during the study period

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lifestyle Intervention

Participants complete lifestyle intervention consisting of high-resistance circuit training, aerobic training, and diet recommendations for 16 weeks

16 weeks

Weekly sessions with health coach or dietitian

Wait-list

Participants are placed on a wait-list before starting the lifestyle intervention

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lifestyle Intervention

Trial Overview The trial tests if lifestyle changes like diet control and physical activities (resistance training and aerobic exercises) can reduce breast cancer risk by decreasing body fat and inflammation in normal-weight women with high breast cancer risk due to excess body fat.

How Is the Trial Designed?

Group I: Group I (lifestyle intervention) Experimental Treatment 5 Interventions

Participants complete lifestyle intervention consisting of 1-3 sets of high-resistance circuit training sessions per week, up to 150 minutes of aerobic training per week, and diet recommendations from a health coach or registered dietitian twice per week for 16 weeks.

Group II: Group II (wait-list, lifestyle intervention) Active Control 5 Interventions

Participants are placed on a wait-list and then complete lifestyle intervention after 4 months.

Lifestyle Intervention is already approved in United States, European Union for the following indications:

Approved in United States as Lifestyle Intervention for:

• Obesity
• Weight Loss
• Type 2 Diabetes Prevention

Approved in European Union as Lifestyle Intervention for:

• Obesity
• Overweight
• Weight-Related Diseases

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Foundation for Women's Cancers

Collaborator

Trials

1

Recruited

50+

Published Research Related to This Trial

Breast cancer (BC) has received significant public attention, but evidence-based preventive strategies are not as well emphasized, despite advancements in treatment for various BC subtypes.

The review aims to highlight key lifestyle factors linked to BC and provide practical prevention strategies that can be implemented in clinical practice, addressing the gap in long-term prevention studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of lifestyle factors on breast cancer risk. Dieterich, M., Stubert, J., Reimer, T., et al.[2020]

Breast cancer is the most diagnosed cancer in women, with 2.3 million new cases in 2020, and lifestyle interventions like a healthy diet and daily exercise can significantly reduce the risk of developing invasive breast cancer and help mitigate treatment side effects.

Despite the clear benefits of lifestyle changes, their implementation among at-risk individuals and survivors remains limited, highlighting the need for better education and outreach from oncology providers to promote these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Healthy Diet and Physical Activity With Breast Cancer: Lifestyle Interventions and Oncology Education. Jia, T., Liu, Y., Fan, Y., et al.[2022]

Maintaining a healthy lifestyle, including regular exercise, weight control, and a plant-based diet, can significantly reduce the risk of developing breast cancer, particularly in postmenopausal women.

Implementing targeted prevention programs for high-risk women and promoting healthy habits during childhood and adolescence could potentially prevent 25% to 30% of breast cancer cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can diet and lifestyle prevent breast cancer: what is the evidence? Harvie, M., Howell, A., Evans, DG.[2022]

Implementing lifestyle education based on the 2018 American Institute for Cancer Research recommendations is a cost-effective strategy for the primary prevention of breast cancer.

Key lifestyle changes include maintaining a healthy weight, adopting a low-fat, plant-based diet, engaging in regular physical activity, and avoiding alcohol, which should be integrated into routine patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle for breast cancer risk reduction. Mussallem, D.[2022]

A predominantly plant-based diet, along with regular physical activity and maintaining a healthy weight, plays a crucial role in preventing breast cancer and supporting treatment.

The article emphasizes the importance of personalized lifestyle recommendations for patients, based on evidence from the World Cancer Research Fund/American Institute for Cancer Research, to enhance cancer prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast Cancer: A Lifestyle Medicine Approach. Orman, A., Johnson, DL., Comander, A., et al.[2021]

Excess body fat and inactivity are linked to a higher risk of developing breast cancer and poorer outcomes for those diagnosed with early-stage breast cancer, highlighting the importance of lifestyle factors in cancer risk.

Ongoing clinical trials are exploring how weight management and physical activity after a breast cancer diagnosis can potentially reduce the risk of recurrence, while also providing additional health benefits like improved metabolism and reduced risk of other diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Management and Physical Activity for Breast Cancer Prevention and Control. Ligibel, JA., Basen-Engquist, K., Bea, JW.[2019]

Lifestyle interventions that include nutrition education, physical activity, and stress management can significantly improve the overall health of breast cancer patients.

Implementing a structured lifestyle intervention program is essential for enhancing the well-being of individuals undergoing treatment for breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle Intervention for Breast Cancer Women. Hwang, ES., Nho, JH.[2020]

The BWEL trial is a large randomized controlled study involving 3,181 women with stage II or III breast cancer, aiming to determine if a telephone-based weight-loss intervention can reduce cancer recurrence risk by promoting a weight loss of at least 10%.

The intervention includes 42 sessions over 2 years focusing on increased physical activity and caloric restriction, with the potential to significantly improve cancer outcomes and influence future care for breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Breast Cancer Weight Loss trial (Alliance A011401): A description and evidence for the lifestyle intervention. Delahanty, LM., Wadden, TA., Goodwin, PJ., et al.[2023]

A pilot study involving 40 women undergoing chemotherapy for breast cancer showed that a weight control program combining a low-fat, high fruit-vegetable diet and moderate physical activity is feasible and well-received, with 75% of participants completing the 12-month study.

The intervention led to significant improvements in fruit and vegetable intake, physical activity, and breast cancer-specific well-being, while participants in the intervention group experienced a decrease in body fat compared to those receiving only written materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Diet and Exercise Intervention during Chemotherapy for Breast Cancer. Djuric, Z., Ellsworth, JS., Weldon, AL., et al.[2021]

The SUCCESS C study is the first European trial to investigate how an intensive lifestyle intervention program affects disease-free survival in 3,547 women with early-stage, Her2/neu-negative breast cancer, highlighting the potential impact of lifestyle changes on cancer outcomes.

The trial will compare two chemotherapy regimens and assess the effectiveness of a telephone-based lifestyle intervention for women with a body mass index of 24-40 kg/m², aiming to determine if weight loss can improve survival rates and reduce recurrence risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The German SUCCESS C Study - The First European Lifestyle Study on Breast Cancer. Rack, B., Andergassen, U., Neugebauer, J., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6350793/

Lifestyle Interventions for Breast Cancer Prevention - PMC At year 6, compared to control, the intervention group reduced percentage of energy from fat by 8.1%, increased fruit and vegetable consumption by 1.1 servings ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0378512224000720

The effects of lifestyle and behavioural interventions on ... This study aimed to assess and compare the effects of lifestyle/behavioural interventions on cancer recurrence, survival and QoL in breast cancer survivors.

3. clinicalnutritionjournal.com clinicalnutritionjournal.com/article/S0261-5614(24)00231-0/fulltext

Effect of a comprehensive lifestyle intervention program on ... The results of this study show that a 24-month, individualized, telephone-delivered lifestyle intervention led to a moderate weight loss of 3–4% ...

4. withpower.com withpower.com/trial/phase-breast-neoplasms-2020-d5230

Lifestyle Changes for Breast Cancer Risk Reduction This trial studies how well a lifestyle intervention works in reducing breast cancer risk through changing body composition and decreasing inflammation in ...

5. academic.oup.com academic.oup.com/oncolo/article/30/7/oyae303/7915797

Evidence for the benefits of lifestyle medicine interventions in ... Physical activity in individuals diagnosed with early-stage breast cancer was associated with reduced risk of breast cancer-specific and all ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06577545?term=androutsos&cond=Breast%20Cancer&rank=1

Lifestyle Behavioural Intervention on Breast Cancer ... The behavioural lifestyle intervention program (BL) group will participate in a 24-week intervention targeting diet and physical activity to lose weight.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7841841/

the lifestyle intervention part of the SUCCESS C Study - PMC This study will provide information on the efficacy and safety of a comprehensive lifestyle intervention programme on disease-free survival in a large cohort ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0261561424002310

Effect of a comprehensive lifestyle intervention program on ... The results of this study show that a 24-month, individualized, telephone-delivered lifestyle intervention led to a moderate weight loss of 3–4% in women with ...

9. withpower.com withpower.com/trial/phase-cancer-prevention-4-2024-1ba75

Lifestyle Intervention for Cancer Prevention The provided research does not directly address safety data for the Lifestyle Intervention for Cancer Prevention or the Enhanced TSSC curriculum. However, it ...

10. mdpi.com mdpi.com/2072-6694/15/19/4719

Randomized Trial Evaluating a Self-Guided Lifestyle ... Background: Lifestyle interventions for breast cancer survivors have proved effective at stimulating positive behavior change and promoting healthy weight loss, ...